The patient's perspective on the need for informed consent for minimal risk studies: Development of a survey-based measure

Abstract

Background: Recent efforts to study quality improvement (QI) efforts to improve the effectiveness and efficiency of healthcare have raised important questions about ethical boundaries for waiving informed consent. Confusion exists because similar projects can be undertaken for research or QI purposes, a distinction currently used to define Institutional Review Board oversight. However, patients are not aware of such distinctions. We sought to evaluate patients' views of waiving consent for non-invasive projects to improve healthcare quality and delivery. Methods: We developed a 32-item measure of patient thresholds for waiving consent for different types of QI interventions, including those involving changes to: 1) the hospital environment; 2) hospital policies or procedures; 3) objects used by patients; 4) medications or devices; and 5) use of patient information. In a sample of 200 hospitalized patients, we tested and confirmed the reliability and validity of subscales representing each of the 5 intervention types. Results: For each of the five consent threshold scales, all items in each scale had substantial itemto-total correlations with the other items in that scale taken together. All five internal consistency reliability coefficients exceeded .70 for the total sample. Means for all 5 scales indicated general patient support for waiving consent across all categories of interventions studied. However, patients were significantly less comfortable foregoing consent for interventions involving medications or devices, or sharing of patient information. Conclusion: We developed and tested a survey instrument to contribute to the understanding of patient preferences for consent in QI assessment activities. Measures were found to be reliable and valid. Findings indicated general patient support for waiving consent across all minimal risk categories studied. However, more work is needed to reassure and protect patients during minimal risk studies involving medications or devices, or the sharing of patient information.

Informed consent within a learning health system: A scoping review

“…Various studies have shown that at first glance, participants seem to favor an “ask each time” model in research . Those findings are inconsistent with the results of two studies exploring public attitudes toward consent in biobanking, both indicating that a broad one‐time opt‐in is preferred by the public in general .…”

“…Specific individual consent with opt‐in is described by several researchers and ethicists as impractical as it would be too time‐consuming and expensive to ask consent from every patient for every research project . Having participants understand the difference between clinical care and research also takes time .…”

Factors affecting willingness to share electronic health data among California consumers

“…Transforming the patient encounter into research data also requires accepting changes to privacy and confidentiality, which are important foundations of patient trust and effective health care. Studies demonstrate broad support among patients and consumers for approaches to improving health care that rely on using patient information [7, 8]. They also have consistently found privacy to be a major concern [9–14].…”

Citizens, research ethics committee members and researchers’ attitude toward information and consent for the secondary use of health data: Implications for research within learning health systems

“…In fact, several studies showed that even if there is good acceptance from the public for research with health data, there is a strong desire of transparency and to be asked for permission before using this information. As illustrated in our scoping review, participants expressed a preference for an "ask me each time" model of consent in research (Flory et al, 2016;Kaplan et al, 2016;Kass et al, 2016;Kelley et al, 2015;Nayak et al, 2015;Sugarman & Califf, 2014;Weinfurt et al, 2016;Whicher et al, 2015). However, the study by Cho et al (2015) noted that when the consent process impacts significantly the feasibility of the research, participants were willing to accept less elaborate approaches.…”

“…As the use of de-identified health data is crucial for certain research projects for which consent cannot always be obtained, this result is not very surprising. Several researchers and ethicists described specific individual consent with opt-in as impractical, as it would be too time consuming and expensive to ask consent from every patient for every research project Hoffman & Podgurski, 2012;Kaplan et al, 2016). Few seem to believe that this approach to consent would fit well the needs of LHSs.…”